Glossary · GxP: good practices
Good distribution practice (GDP)
Also known as: GDP, EU GDP guidelines, Good distribution practice of medicinal products
Good distribution practice (GDP) is the part of quality assurance that ensures the quality and integrity of medicinal products are maintained throughout the supply chain, from the manufacturer's release to the pharmacy or other person authorized to supply the public. In the EU it is set out in the Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01).
- GxP
- Pharma
- EU
In one sentence
GDP keeps medicinal products' quality intact from release to pharmacy: storage, transport, temperature control and traceability in the supply chain.
Example
A wholesaler qualifies the refrigerated trucks of its transport contractor, maps the temperature of its warehouse, and documents how it handles a shipment that arrived outside its 2–8 °C range.
How it applies
- Who it binds: Holders of a wholesale distribution authorization. Each must designate a responsible person for GDP.
- Content: The guidelines cover the quality system, personnel, premises and equipment, documentation, operations, complaints, returns, suspected falsified products and recalls, outsourced activities, self-inspections and transportation.
- Temperature control: Storage areas and transport must keep products within their labeled conditions; equipment is qualified and deviations are investigated.
- Technical documentation: Records must allow every transaction to be traced: supplier, customer, product, batch, quantity and date. Temperature records and deviation reports are part of the evidence.
GDP vs. GMP
GMP ends with batch release by the manufacturer; GDP begins there and covers everything until the product reaches the dispensing point. Storage at the manufacturing site before release is GMP; storage at a wholesaler is GDP. Note that the abbreviation GDP is sometimes also used for good documentation practice, which this glossary abbreviates as GDocP.